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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04291586
Other study ID # Casa de Saúde Câmara Pestana
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 3, 2019
Est. completion date March 31, 2020

Study information

Verified date January 2021
Source Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Virtual Reality allows the integration of cognitive rehabilitation in a more ecologically valid context. The purpose of this study is to determine whether this methodology has more impact on psychosocial rehabilitation than a paper and pencil personalized program.


Description:

Cognitive impairments are frequently present on many psychiatric diseases, such as schizophrenia, depression, etc. and are not always given sufficient attention despite its limitations in activities of daily living (ADL's). Current cognitive rehabilitation methods mostly rely on paper-and-pencil tasks targeting isolated domains, which is not consistent with everyday life, and have limited ecological validity. Virtual Reality (VR) has shown to be a solution for the development of accessible and ecologically valid systems but, does it have more impact than a paper and pencil personalized intervention? Through a participatory design approach, with health professionals, the investigators have developed: a motor-accessible and cognitive-personalized VR-based system, where conventional cognitive tasks were operationalized in meaningful simulations of ADL's (Reh@City) and; a web tool which generates personalized paper and pencil tasks (Task Generator). The investigators goal is to have a sample of 30 inpatients from a psychosocial rehabilitation unit, with no age limit, randomly allocated in two groups: 1) the experimental group, where participants will perform 30 minutes of the VR training with Reh@City; and 2) the control group, where participants will perform 30 minutes of the paper and pencil training with the Task Generator.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date March 31, 2020
Est. primary completion date February 7, 2020
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Inpatients of psychosocial rehabilitation unit; - Cognitive deficit but with enough capacity to understand the task and follow instructions; - Able to read and write. Exclusion Criteria: - Patients experiencing an acute psychiatric episode.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Virtual reality
Virtual Reality Intervention of 30 minutes, 3 times a week until reaching 24 sessions.
Paper and Pencil
Paper and Pencil Intervention of 30 minutes, 3 times a week until reaching 24 sessions.

Locations

Country Name City State
Portugal Instituto das Irmãs Hospitaleiras do Sagrado Coração de Jesus - Casa de Saúde Câmara Pestana Funchal Funchal-Madeira

Sponsors (2)

Lead Sponsor Collaborator
Instituto Irmãs Hospitaleiras Sagrado Coração de Jesus Universidade da Madeira

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Other Beck Depression Inventory - II Change from baseline in the Beck Depression Inventory - II. It is a self-report inventory that aims to measure the severity of depression. Can be scored between 0-63. Minimal depression, 0-11; Mild depression, 12-18; Moderate depression, 19-24; Severe depression, above 25. Baseline, End (8 weeks) and 8-weeks follow-up
Other Barthel Index Change from baseline in the Barthel Index. It's a scale that measures functionality, with features of activities of daily living with the item: bowel control, bladder control, personal hygiene, using the toilet, eating, transferring, walking on a level surface, getting dressed and undressed, going up and down stairs, taking a shower. The maximum score obtainable is 100 points: scores between 91-99, correspond to slight dependence; 61-90, to moderate dependence; 21-60, to serious dependence; and 0-20, to total dependence. Baseline, End (8 weeks) and 8-weeks follow-up
Other Katz Index Change from baseline in the Katz Index. It's a scale that measures functionality, with features of activities of daily living with the item: showering, dressing, using the toilet, sphincter control, mobility and eating. The highest score obtainable is 6, corresponding to independent; scores between 3 and 5, correspond to moderate dependence; and scores below 2, correspond to very dependent. Baseline, End (8 weeks) and 8-weeks follow-up
Other World Health Organization Quality of Life - Bref (WHOQOL-Bref) - Quality of Life Assessment Change from baseline in the WHOQOL-Bref Quality of Life Assessment. This scale is divided in four domains, physical health, social, psychological and environmental. For the physical health we use the questions: 3 (inverse), 4 (inverse),10,15, 16, 17, 18. For the psychological, questions: 5, 6, 7, 11, 19, 26 (inverse). For the social domain, the questions: 20, 21, 22. For the environmental domain, the questions: 8, 9, 12, 13, 14, 23, 24, 25. The main score is obtained through the sum of the four domains and higher scores correspond to higher perceived quality of life. Baseline, End (8 weeks) and 8-weeks follow-up
Primary Montreal Cognitive Assessment (Cognitive Screening) Change from baseline in the Montreal Cognitive Assessment. Higher values represent better outcomes. Baseline, End (8 weeks) and 8-weeks follow-up
Secondary Toulouse-Pieron (Attention) Change from baseline in the Toulouse-Pieron Cancellation Test. Baseline, End (8 weeks) and 8-weeks follow-up
Secondary Semantic Fluency and Phonemic Fluency Tests Change from baseline in the Semantic Fluency and Phonemic Fluency Tests Baseline, End (8 weeks) and 8-weeks follow-up
Secondary Verbal Paired Associates (WMS-III) (Memory) Change from baseline in the Verbal Paired Associates (WMS-III) Baseline, End (8 weeks) and 8-weeks follow-up
Secondary Rey Complex Figure Change from baseline in the Rey Complex Figure Baseline, End (8 weeks) and 8-weeks follow-up
Secondary Symbol Search and Coding (WAIS III) Change from baseline in the Symbol Search and Coding (WAIS III) Baseline, End (8 weeks) and 8-weeks follow-up
Secondary Rey 15-Item Memory Test Change from baseline in the Rey 15-Item Memory Test Baseline, End (8 weeks) and 8-weeks follow-up
See also
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